Robotic Knee Testing (RKT) Device Having Decoupled Drive Capability and Systems and Methods Providing The Same

ABSTRACT

Various limb manipulation and evaluation devices are provided. The devices generally include three drives, namely a first drive configured to manipulate a first bone relative to a second bone in a first direction, a second drive configured to manipulate the first bone relative to the second bone in a second direction, a third drive configured to manipulate the first bone relative to the second bone in a second direction. The three directions are different relative to each other and in some embodiments represent three distinct axes. The devices are further configured such that at least one of the drives is mutually decoupled relative to at least one other drive, such that operation of the one drive does not affect the position or movement of the another drive. One or multiple of the drives may be decoupled. A corresponding method of operating such decoupled drives is also provided.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.14/029,780, filed Sep. 17, 2013, and entitled “Robotic Knee Testing(RKT) Device Having Decoupled Drive Capability and Systems and MethodsProviding The Same,” which, in turn, claims priority to and the benefitof U.S. Provisional Application Ser. No. 61/702,105, filed Sep. 17,2012, the contents of which are hereby incorporated herein by referencein their entirety.

BACKGROUND Field of Invention

This generally relates to three-dimensional joint motion evaluationusing computer-controlled torque application via, for example, a roboticknee testing device (an “RKT” device) which controls the direction,rate, and magnitude of forces applied in at least three directions. Therespective forces are configured to evaluate “IE” (internal-external)movement about a Z-axis of rotation distal to the foot, varus-valgusconditions about a Y-axis of rotation distal to the foot, and “AP”(anterior-posterior) movement of the tibia through a proximal tibiacontact arm which rotates about a X-axis of rotation distal to the foot.

Description of Related Art

The knee is composed of the femur or thigh bone, the tibia or shin boneand the patella or knee cap. They are connected by fibrous structurescalled ligaments which allow a certain amount of ‘joint play’ or motionto exist between the bone structures. When this ‘joint play’ isincreased or decreased, an abnormal or pathological condition exists inthe knee. Attempts have been made in the past to quantify this increaseor decrease in ‘joint play’ of the knee with limited success.

An injury to the knee can cause damage to one or more of the structuresof the knee causing an increase in the ‘joint play’ or motion of theknee. This increase in ‘joint play’ can create the sensation to thepatient that the knee is slipping or ‘coming out of joint’. Commonly,this sensation described by the patient is referred to as the feeling of‘joint instability’. The ability of the two bones to actually ‘come outof joint’ is related to the length of the fibrous structures orligaments which connect the two bones together as well as the shape andsize of the two bones (or three). The ability of the bones to ‘come outof joint’ or become unstable is related to the amount of stretch or theamount of increased lengthening of each ligament, the number ofligaments involved, and damage to other support structures of the kneesuch as the bone itself and the menisci. Accurate measurement of thisincreased ligament length can be critical to restore the knee to asclose to its original functional and anatomical state as possible.

Currently, there are only manual tests used by clinicians to aid in thediagnosis of ligament damage resulting in a change in joint play. As anexample, there are three manual tests to evaluate the increased jointplay associated with an ACL tear—the Lachman's test, the Pivot Shifttest and the Anterior Drawer Test. All of these tests suffer from theclinician's subjective evaluation of both the extent of the ligamentlengthening and the change in the compliance or stretchiness of theligament.

The Lachman's test is performed by laying the patient in a supineposition and bending the knee at approximately 20 to 30 degrees. Theclinician places a hand on the patient's upper thigh and his other handbelow the upper part of the patient's calf. Pressure is applied underthe patient's calf and down on the patient's thigh such that there is atranslation between the femur and the tibia.

Similar to the Lachman's test, the pivot shift test begins bypositioning the patient on his back. The knee is placed in fullextension (x-axis rotation) and a valgus (y-axis rotation) force and aninternal rotation (z-axis rotation) force is applied to the knee toallow the lateral tibia to slip anteriorly from underneath the lateralfemoral condyle as the knee is flexed (x-rotation) the tibia is allowedto slip suddenly back underneath the femoral condyle. The clinicianfeels for an abnormal external rotation (z-axis rotation) and posteriortranslation (y-axis translation) of the tibia with respect to the femur.This shift is felt to represent the relative increased translation(y-axis translation) of the lateral side of the knee with respect to theincreased translation (y-axis translation) of the medial side of theknee. Furthermore, the point of sudden shift represents the point atwhich the tibia bone slides from in front of the radius of curvature ofthe curved end of the femur back to its normal position under thefemoral condyle. The clinician subjectively rates the pivot shift asGrade I, Grade II or Grade III depending upon the degree of rotationaland translational shift felt during the test. This test is difficult toperform, difficult to teach and difficult to quantify.

Finally, the anterior drawer test is performed with the patient lying onhis back and his knee bent 90 degrees. With the patient's foot supportedby a table or chair, the clinician applies pressure to the knee usingher thumbs. This test is graded based on the amount or extent ofanterior translation of the tibia with respect to the femur. Grade I has0 to 5 mm of anterior translation Grade II has 6 to 10 mm of anteriortranslation, and Grade III has 11 to 15 mm of anterior translation.

To diagnose an injured ACL using the described tests, the clinician mustdetermine whether the knee feels “abnormal.” Thus, the accuracy of anACL injury diagnosis using currently known tests depends on the skilland experience of the clinician. A misdiagnosis can lead to unnecessarydelay in treatment, thereby placing the patient at increased risk forfurther damage to the knee.

There are manual tests for the LCL, MCL and the PCL. Each manual testrelies on grading the ligament lengthening based upon relative increasein joint play into three categories. There is no effort to grade thecompliance of the ligament; however, the expert clinician will describethe ligament in terms of its ‘feel’. The more ligaments and structuresthat are damaged; the more complex it becomes to perform a manual kneeexamination with accuracy.

There have been multiple attempts in the past to instrument the knee andquantify or measure the change in the structure of the knee afterligament damage. Several devices have attempted to accurately quantifythe extent or relative displacement and compliance of a ligament in theknee. One of these devices is The KT-1000 and the KT-2000 Medmetric®,which measures the anterior-posterior translation of the tibia withrespect to the femur along the y-axis, but disadvantageously attach tothe tibia. These devices attempt to quantify the findings found when theclinician uses the Lachman's test and the Anterior Drawer Test. Force isapplied to a handle on the device which measures force and signals tothe clinician the amount of force with a low pitched sound for a 15pound force and a higher pitched sound for a 20 pound force. This forcepulls anteriorly along the y-axis through a strap that wraps underneaththe calf. The measurement of the translation uses a technique measuringthe relative motion of a pad on the anterior tibia with respect to a padplaced on the patella. This device does not measure relativedisplacement or compliance in any of the other degrees of freedompreviously described in the knee. Furthermore, the quantified results ofthe KT-1000 or KT-2000 have not been correlated with patientsatisfaction whereas the subjective Pivot Shift test has been correlatedwith patient satisfaction. Other devices such as the Stryker KLT, theRolimeter, and the KSS system use similar mechanisms to attempt toquantify the normal amount of ‘joint play’ or motion between the femurand tibia, along with any increased ‘joint play’ or motion which isassociated with ligament lengthening and damage.

Many non-invasive systems utilize sensors or markers that are attachedto the skin, including but not limited to optoelectronic, ultrasonic,and electromagnetic motion analysis systems. These skin sensors ormarkers are merely representations of location of the underlying bones;however, many published reports have documented the measurement errorrelated to skin artifact with this system. In order to avoid theinaccuracies associated with skin artifact, medical imaging systems maybe utilized in order to precisely determine the position/location of thebones accurately.

Surgeons manually examine the joint for altered play; however, due tothe variability in size of the patient, size and experience of thesurgeon, and the subtlety of injury, consistent and reproducible reportsof joint play between surgeons is not possible. The need that must bemet is to provide a controlled application of torque during jointexamination, with the magnitude, direction, and rate of torqueapplication being controlled. Many reports have documented that, whetherperformed by hand or with manual arthrometers, the manual application oftorque varies between clinicians, thus creating inconsistencies in theexamination of joint play.

Accordingly, there is a need for an accurate, objective, reliable andreproducible measure of the impact of damage to the ACL as well as otherligaments and structures in the knee or combination of ligaments andother structures in the knee that can be used in the clinical setting onpatients. For example, since an injury to the ACL produces both anincrease in anterior translation (y-axis translation) and rotation(z-axis rotation), an objective measure of these changes would both aidin the diagnosis of the injury as well as verify its restoration afterligament reconstruction surgery. Additionally, measurement ofdisplacement and compliance around different degrees of freedom in theknee would help objectively describe the individual and complex changesto ‘joint play’ that occurs in an injured knee with structural damage. Aneed exists for systems and methods that can provide accurate,reproducible and objective data on the changes in ‘joint play’ or motionthat occurs with an injured knee compared to their healthy knee and tothe population as a whole such that the clinician can achieve patientsatisfaction with focused, biomechanical and proven surgicalinterventions specific to that injury and for that knee across theentire population of damaged knees.

Needs also exist for systems and methods, and devices which accommodatevariances of patient body structure; it may well be understood that eachhuman body is different and may require particular attention when beingtreated and/or analyzed; this may be particularly evident in the case ofabnormalities of bones, tendons, joints, etc., due to injury or thelike. Needs also exists for systems and methods, and devices that canprovide the type of accurate, reproducible and objective data describedabove without inherently and/or indirectly adversely impacting theaccuracy, reproducibility, and/or objectiveness of the tests andmeasured data therein.

SUMMARY

Generally described, the present invention to provide apparatuses andmethods for evaluating the performance of joints and their associatedelements, as described elsewhere herein.

According to various embodiments a limb manipulation and evaluationdevice including three drives is provided. The device comprises: a firstdrive configured to manipulate a first bone relative to a second bone ina first direction; a second drive configured to manipulate the firstbone relative to the second bone in a second direction; and a thirddrive configured to manipulate the first bone relative to the secondbone in a second direction. The first, second, and third directions aredifferent relative to each other, and at least one of the drives ismutually decoupled relative to another drive, such that operation of theone drive does not affect the position or movement of the another drive.

According to various embodiments a limb manipulation and evaluationdevice including three drives is provided. The device comprises: a firstdrive configured to manipulate a first bone relative to a second boneabout a first axis; a second drive configured to manipulate the firstbone relative to the second bone about a second axis; and a third driveconfigured to manipulate the first bone relative to the second boneabout a third axis, wherein: the first, second, and third axes are eachoriented at an angle relative to each other, and at least one of thedrives is mutually decoupled relative to another of the drives, suchthat operation of the one drive does not affect the rotational axis ofthe another of the drives.

According to various embodiments a limb manipulation and evaluationdevice including three drives is provided. The device comprises: a firstdrive configured to manipulate a first bone relative to a second boneabout a first axis, a second drive configured to manipulate the firstbone relative to the second bone about a second axis, and a third driveconfigured to manipulate the first bone relative to the second boneabout a third axis, wherein: the first, second, and third axes are eachoriented at an angle relative to each other, and at least two of thedrives are decoupled relative to a third drive, such that operation ofeither of the two drives does not affect the rotational axis of thethird drive.

According to various embodiments a limb manipulation and evaluationdevice including three drives is provided. The device comprises: a firstdrive configured to manipulate a first bone relative to a second boneabout a first axis, a second drive configured to manipulate the firstbone relative to the second bone about a second axis, and a third driveconfigured to manipulate the first bone relative to the second boneabout a third axis, wherein: the first, second, and third axes are eachoriented at an angle relative to each other, and at least one of thedrives is mutually decoupled relative to the other two drives, such thatoperation of the at least one drive does not affect the rotational axisof the other two drives.

According to various embodiments a limb manipulation and evaluationdevice including three drives is provided. The device comprises: a firstdrive configured to manipulate a tibia relative to a femur about a firstaxis, the first drive providing internal and external rotation of thetibia relative to the femur; a second drive configured to manipulate thetibia relative to the femur about a second axis, the second driveproviding anterior-posterior movement of the tibia relative to thefemur, and a third drive configured to manipulate the tibia relative toa femur about a third axis, the third drive providing valgus-varusmovement of the tibia relative to the femur, wherein: the first, second,and third axes are each oriented at an angle relative to each other; thefirst drive is decoupled from the second drive; and the first and seconddrives are coupled with the third drive.

According to various embodiments a limb manipulation and evaluationdevice including three drives is provided. The device comprises: a firstdrive configured to manipulate a tibia relative to a femur about a firstaxis, the first drive providing internal and external rotation of thetibia relative to the femur; a second drive configured to manipulate thetibia relative to the femur about a second axis, the second driveproviding anterior-posterior movement of the tibia relative to thefemur, and a third drive configured to manipulate the tibia relative toa femur about a third axis, the third drive providing valgus-varusmovement of the tibia relative to the femur, wherein: the first, second,and third axes are each oriented at an angle relative to each other; thefirst drive is coupled to the third drive; the second drive is decoupledfrom the first and third drives; and the third drive is decoupled fromthe first and second drives.

According to various embodiments a method of using three drives tomanipulate a first bone relative to a second bone is provided. Themethod comprises the steps of: operating a first drive configured tomanipulate the first bone relative to the second bone about a firstaxis; operating a second drive configured to manipulate the first bonerelative to the second bone about a second axis; and operating a thirddrive configured to manipulate the first bone relative to the secondbone about a third axis, wherein: the first, second, and third axes areeach oriented at an angle relative to each other, and the operation ofat least one of the drives is mutually decoupled relative to another ofthe drives, such that the operation of the one drive does not affect therotational axis of the another of the drives.

BRIEF DESCRIPTION OF THE DRAWINGS

Having thus described the invention in general terms, reference will nowbe made to the accompanying drawings, which are not necessarily toscale. In the drawings:

FIG. 1 is a perspective view of the overall device 10, including twotibia positioning assemblies 1000 according to various embodiments;

FIG. 2 is a view of a portion of FIG. 1, and in particular illustrates aperspective view of the two tibia positioning assemblies 1000 accordingto various embodiments;

FIG. 3 is an isolated view of one of the two tibia positioningassemblies 1000 according to various embodiments;

FIG. 4 is an exploded view of the various elements of the tibiapositioning assembly 1000 of FIG. 3 according to various embodiments;

FIG. 5 is a view of the tibia positioning assembly 1000 of FIG. 3, butfrom an alternative facing perspective relative to that of FIG. 3,illustrating exemplary axes X, Y, and Z of rotation, along with calfbias assembly 1500 according to various embodiments;

FIG. 6 is yet another view of the tibia positioning assembly 1000 ofFIGS. 3 and 5, also illustrating an exemplary foot plate assembly 1300according to various embodiments;

FIG. 7 is an exploded view of the various element of a sliding frameassembly 1100 and a “Y” axis drive assembly 2100 of the tibiapositioning assembly 1000 of FIG. 3 according to various embodiments;

FIG. 8 is a top plan view of the tibia positioning assembly 1000 of FIG.3, in an exemplary “right leg” configuration according to variousembodiments;

FIG. 9 is a side view of the tibia positioning assembly 1000 of FIG. 8according to various embodiments;

FIGS. 10 and 11 illustrate two sequential steps of movement of thedevice during operation of a “X” axis drive assembly 2000 according tovarious embodiments;

FIG. 12 illustrates a view along the “Z” axis of the tibia positioningassembly 1000 of FIG. 3 according to various embodiments, furtherillustrating exemplary X, Y, and Z axis drive assemblies 2000, 2100, and2200 (note that the illustrated “Z” axis extends positive perpendicularto the foot plate extending distal to the foot plate, the illustrated“Y” axis extends positive straight up from “Z” axis and away fromfloor/ground, and the illustrated “X” axis is parallel to the bottom ofthe foot plate and is also parallel to the floor/ground according tovarious embodiments so as to provide three mutually orthogonal axes);

FIG. 13 is an alternate configuration according to various embodiments,illustrating the use of exemplary spherical elements 3001, 3002 formanipulating the lower leg of a patient (shown in dotted line) aboutcenters of the spheres, wherein sphere 3001 is driven by an exemplaryroller and drive assembly 3001A;

FIG. 14 is another alternate configuration illustrating the use of anexemplary spherical element 3003 according to various embodiments, witha center of rotation C3 located even further distal to the foot and anexemplary calf bias member (aka extender bar); and

FIG. 15 is yet another alternate configuration including a sphericalcage 4000 comprised of a plurality of cage bars 4005 according tovarious embodiments.

FIG. 16 shows an alternate configuration for the L Bracket 1220, in thatL Bracket 1220, which supports the Z Drive motor, can if desired slidealong the Z axis relative to pivoting plate assembly 1200 in order toaccommodate “pistoning” of foot in varus valgus procedure, allowing forthe foot to move in a more natural arc during varus-valgus testing. Thefoot plate and motor all move together.

FIG. 17 is a side illustrative view of a leg testing apparatus 5000, incombination with an exemplary CT scanner 4900, and a patient's bodysupport apparatus 4950. The three devices are configured to be typicallysituated atop an unnumbered supporting surface. Also shown is anexemplary patient, including a patient upper body 4951, patient lowerleg 4950, and patient upper leg 4950.

The patient body support apparatus 4950 includes a patient back support4956, a shoulder restraint 4959, and a thigh restraint 4952.

FIG. 18 is a perspective view of a leg testing apparatus 5000 accordingto one aspect of the present inventions, which includes left lower legsupporting apparatus 5200, right lower leg supporting apparatus 5300,and lower frame number 5100. As maybe seen, the “Z” axes of the twoapparatuses 5200, and 5300, are not aligned. This will be discussedelsewhere in this application.

FIG. 19 is a top elevation view of the leg testing apparatus 5000 ofFIG. 18, illustrating the relationship of the left lower leg supportingapparatus 5200 and the right lower leg supporting apparatus 5300,relative to the inner surface of the scanning device 4900. As may beseen, the “X” axes of the two apparatuses 5200, and 5300, are also notaligned, and in the embodiment shown, the angle between the two isfixed.

FIG. 20 is a rear elevation view of the leg testing apparatus 5000 ofFIG. 18, which includes left lower leg supporting apparatus 5200, rightlower leg supporting apparatus 5300, and lower frame number 5100.

FIG. 21 is a front elevation view of the leg testing apparatus 5000 ofFIG. 20.

FIG. 22 is a pictorial view of the right lower leg supporting apparatus5300, with certain elements not included for purposes of explanation.

FIG. 23 is a right side elevation view of the right lower leg supportingapparatus 5300, with certain elements not shown for purposes ofexplanation.

FIG. 24 is a pictorial view of a portion of the right lower legsupporting apparatus 5300 of FIG. 23, showing certain details.

FIG. 25 is a pictorial view of a portion of the right lower legsupporting apparatus 5300, taken from the opposite side as that shown inFIG. 24.

FIGS. 26A and 26B show two sequential illustrative views similar to FIG.17, except that the leg testing apparatus 5000 is configured to be movedbetween the two positions shown, resulting in different flexions of theknee (Note that 26A knee is in a more extended position than the 26Bknee.)

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

Various embodiments of the present invention will now be described morefully hereinafter with reference to the accompanying drawings, in whichsome, but not all embodiments of the invention are shown. Indeed,embodiments of the invention may be embodied in many different forms andshould not be construed as limited to the embodiments set forth herein.Rather, these embodiments are provided so that this disclosure willsatisfy applicable legal requirements. Unless otherwise defined, alltechnical and scientific terms used herein have the same meaning ascommonly known and understood by one of ordinary skill in the art towhich the invention relates. The term “or” is used herein in both thealternative and conjunctive sense, unless otherwise indicated. Likenumbers refer to like elements throughout.

I. ELEMENT LIST

-   -   10 Overall RKT apparatus    -   20 main frame assembly    -   30 support cushion    -   40 sliding support framework    -   50 pivoting leg support frame assemblies (2)    -   60 knee support/stabilizing assemblies (2)    -   80 thigh retention assemblies (2)    -   1000 tibia positioning assembly    -   1100 sliding frame assembly (supports Y drive assembly)    -   1101 sliding frame members (FIG. 7)    -   1102 bearings (FIG. 7)    -   1103 flange adaptor (FIG. 7)    -   1104 torque transducer (Y axis)    -   1110 frame cap assembly (attached to pivot plate)    -   1200 pivoting plate assembly (supports X/Z/yoke/calf)    -   1201 pivoting plate    -   1210 L-shaped flange brackets (2) (support X)    -   1211 bearing (support X)    -   1212 stub flange (supports yoke/calf)    -   1213 flange bracket (supports yoke/calf    -   1220 L bracket (support Z)    -   1221 flange adaptor (support Z)    -   1222 torque transducer (Z axis)    -   1300 foot rotation assembly    -   1400 yoke assembly (FIG. 4)    -   1410 yoke top plate    -   1420 yoke end plates (2)    -   1430 limit plate    -   1500 calf bias assembly    -   1510 side leg members (2)    -   1520 plate    -   1530 torque transducer (X axis)    -   1540 stub flange    -   1550 bearing    -   1560 telescoping rod assembly    -   1570 calf bias plate    -   2000 x-axis drive assembly    -   2010 drive motor    -   2020 gear box    -   2030 output shaft    -   2100 y-axis drive assembly    -   2130 output shaft    -   2200 z-axis drive assembly    -   2210 drive motor    -   2220 gear box    -   2230 output shaft    -   3001 Spherical member (with center C1)    -   3002 Spherical member (with center C2)    -   3003 Spherical member (with center C3)    -   4000 Spherical cage    -   4900 Exemplary CT scanning device    -   4950 Patient body support apparatus    -   4951 Link    -   4952 Patient thigh restraints    -   4956 Patient back support    -   4959 Patient shoulder restraint    -   4960 Patient body    -   4961 Patient upper body    -   4962 Patient upper leg    -   4964 Patient Lower leg    -   5000 Overall Leg Testing Apparatus    -   5100 Lower Frame Member    -   5101 Slide assemblies (4 shown)    -   5200 Left Lower Leg Supporting Apparatus    -   5260 Calf bias assembly    -   5300 Right Lower Leg Supporting Apparatus    -   5400 X Drive Assembly (for AP)    -   5502 Vertical Shaft    -   5504 Lower Bearing    -   5505 Upper Bearing    -   5507 Plate-to-shaft mounting flange    -   5600 Z Drive Assembly (for internal and external rotation)    -   5300 Right Lower Leg Supporting Apparatus    -   5310 Lower Vertical Frame Members (2)    -   5312 Lower Frame Table    -   5314 Intermediate Vertical Frame Members (2)    -   5320 Intermediate Frame Table    -   5322 Short Upper Vertical Frame Members (2)    -   5330 Upper Frame Table    -   5332 Long Upper Vertical Frame Members (2)    -   5340 Pivoting Horizontal Foot Support Plate    -   5341 Pivoting Vertical Foot Support Flange    -   5344 Foot Plate    -   5350 Yoke Assembly    -   5342 yoke top plate    -   5344 yoke end plates (2)    -   5346 limit plate    -   5360 Calf bias assembly (Similar to calf bias assembly 1500)    -   5362 Calf bias plate    -   5363 Extendible rod assembly    -   5364 Side leg members (2)

II. DETAILED DESCRIPTION

Reference will now be made in detail to one or more embodiments of thepresent assembly, an example of which is illustrated in the accompanyingdrawings. The embodiments are described by way of explanation, and notby way of limitation. Indeed, embodiments of the invention may beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein. Rather, these embodiments areprovided so that this disclosure will satisfy applicable legalrequirements.

A) The Overall Apparatus 10

1. Generally

As illustrated in at least FIGS. 1-4, various embodiments of the overallRKT (Robotic Knee Testing) device 10 may include the following features:

-   -   Main Frame Assembly 20 (FIG. 2);    -   Support Cushion 30 (FIG. 2);    -   Sliding Support Framework 40 (FIG. 2);    -   Two (2) Pivoting Leg Support Frame Assemblies 50 (FIG. 2);    -   Two (2) Knee Support/Stabilizing Assemblies 60 (FIG. 2);    -   Two (2) Thigh Retention Assemblies 80 (FIG. 2);    -   Two (2) Tibia Positioning Assemblies 1000 (FIG. 2);    -   Sliding Frame Assembly 1100 (FIG. 3);    -   Pivoting Plate Assembly 1200 (FIG. 4);    -   Two (2) Foot Rotation Assemblies 1300 (FIG. 3);    -   Yoke Assembly 1400 (FIG. 3);    -   Calf Bias Assembly 1500 (FIG. 3);    -   “X”-axis Drive Assembly 2000 (FIG. 4):    -   “Y”-axis Drive Assembly 2100 (FIG. 4); and    -   “Z”-axis Drive Assembly 2200 (FIG. 4).

With particular reference to FIG. 2, it should be understood thataccording to various embodiments, at least certain elements of theoverall RKT device 10 may be sized, shaped, and/or configured insubstantially the same manner as the device described in co-owned U.S.Patent Application Publication No. 2012/0046540-A1 (also Ser. No.13/209,380), as published on Feb. 23, 2012 and filed on Aug. 13, 2011,which is hereby incorporated by reference in its entirety. Asnon-limiting examples, the main frame assembly 20, the support cushion30, the sliding support framework 40, the pivoting leg support frameassembly 50, the knee support/stabilizing assembly 60, and the thighretention assembly 80 illustrated in at least FIG. 2 may be configured,sized, and/or shaped substantially the same as the comparable elements,as described in Ser. No. 13/209,380, which is, as previously noted,incorporated by reference in its entirety herein. Of course, certainembodiments, including those indicated hereinabove or otherwise, of theoverall RKT device 10 may have one or more of these elements sized,shaped, and/or configured in a substantially different manner than thatdescribed in Ser. No. 13/209,380, as may be desirable for one or moreapplications.

In use, as will be described in further detail below, a patient (seeFIGS. 10-11) may be positioned within the various embodiments of theoverall RKT device 10, such that their knees are adjacent the kneesupport/stabilizing assemblies 60, their thighs are adjacent the thighretention assemblies 80, and their feet are retained within the tibiapivoting assemblies 1000, particularly adjacent a foot plate 1300thereof (see FIG. 4).

Movement of the lower leg of the patient may be detected by non-invasivesystems utilizes sensors or markers that are attached to the skin,including but not limited to optoelectronic, ultrasonic, andelectromagnetic motion analysis systems.

2. Tibia Positioning Assemblies 1000

According to various embodiments, with reference to FIG. 2, the overallRKT device 10 comprises may comprise two tibia positioning assemblies1000, each generally configured to support and/or constrain at least oneof a patient's tibia and foot so as to facilitate evaluation of movementthereof in response to the imposition of one or more forces about one ormore axes (e.g., the X, Y, and/or Z axes, as described later herein). Incertain embodiments, the two the tibia positioning assemblies 1000 maybe substantially identical in size, shape, and configuration. In otherembodiments, only a single tibia positioning assembly 1000 may beprovided, for example, where only a single leg of a patient is ofconcern for treatment.

It should be noted, however, that according to various embodiments, atleast the X-axis drive assemblies 2000 of FIG. 4 that form a portion ofeach tibia positioning assembly 1000 may be configured so as to besubstantially mirror images of one another, even though such aconfiguration is not expressly illustrated in FIG. 2. Instead, in theillustrated embodiment of FIG. 2, the “X” axis drive assemblies 2000(see again FIG. 4) are not substantially mirror images of one another,as may be desirable for certain applications. In those embodimentsinvolving mirror image positioned X axis drive assemblies 2000, however,it should be understood that when certain movements (e.g.,anterior-posterior, varus-valgus, internal-external rotation, etc.) areimposed upon the patient's limb during operation, the same movement andin particular the same orientation of movement will be imposed upon bothlimbs. As a non-limiting example, when anterior movement is imposed upona patient's first tibia via rotation of one of the drive assemblies, thesame activation signal will likewise impose anterior movement upon thepatient's second tibia in those embodiments having the X axis driveassemblies positioned as substantial mirror images relative to oneanother. In contrast, in those other embodiments, as may be desirablefor particular applications, where the tibia positioning assemblies 1000may not be “mirror-imaged” relative to one another, a single activationsignal would impose anterior movement upon one tibia and posteriormovement upon the other (or varus upon one and valgus upon the other, orinternal rotation upon one and external rotation upon the other, etc.).This should be understood with reference to at least FIGS. 2 and 4 inconcert with one another.

With that in mind and turning now to FIGS. 3 and 4 in combination,various embodiments of each tibia positioning assembly 1000 (isolatedfor purposes of a concise and clear disclosure) generally comprise asliding frame assembly 1100, a pivoting plate assembly 1200, a footrotation assembly 1300, a yoke assembly 1400, a calf bias assembly 1500,a X-axis drive assembly 2000, a Y-axis drive assembly 2100, and a Z axisdrive assembly 2200. These assemblies will now be described, in turn,below.

3. Sliding Frame Assembly 1100

According to various embodiments, each tibia positioning assembly 1000comprises a sliding frame assembly 1100 that provides an interfacebetween at least the Y-axis drive assembly 2100 and the main frameassembly 20 of the RKT device 10. As may be seen from FIG. 2, thesliding frame assembly 1100 is, in certain embodiments, linearlyslidable along the pivoting leg support frame assembly 50, so as toaccommodate varying lengths of patient legs. In at least one embodiment,the sliding frame assembly 1100 may be configured for translationalmovement relative to the pivoting leg support frame assembly 50 and/orthe main frame assembly 20 of the RKT device 10 in a mannersubstantially the same as the sliding frame 120 described in Ser. No.13/209,380, as incorporated by reference herein and as may be desirablefor one or more applications.

Turning for a moment to FIG. 7, it may be seen that the sliding frameassembly 1100 generally comprises a plurality of sliding frame members1101, each configured to form a platform for substantially supporting afirst (e.g., lower positioned) portion of the Y-axis drive assembly2100. In certain embodiments, the sliding frame assembly 1100 comprisesa pair of bearings 1102 and a flange adaptor 1103 configured to attach asecond (e.g., higher positioned) portion of the Y-axis drive assembly2100 relative to the pivoting plate assembly 1200, as will be describedin further detail below. A torque transducer 1104 may also be providedto evaluate the torque along the drive line between an output shaft 2130of the Y-axis drive assembly 2100 and a pivoting plate 1201, all as willbe described in further detail below. In these and still otherembodiments, the sliding frame assembly 1100 may further comprise aframe cap assembly 1110, which incorporates a plurality of members(shown, but not numbered) that cover (and thus protect) the secondportion of the Y-axis drive assembly 2100.

Remaining with FIG. 7 and also with reference to FIGS. 5-6, it should beunderstood that the sliding frame assembly 1100, beyond being configuredto permit selectable translational movement thereof relative to the mainframe assembly 20 of the RKT device 10, is configured to support theY-axis drive assembly 2100 such that a longitudinal axis thereof liessubstantially along the Y-axis (see in particular FIGS. 5 and 6). Inthis manner, during operation of the RKT device 10, activation of theY-axis drive assembly 2100 provides rotation about the Y-axis. As shouldbe understood from FIGS. 1-4 generally, such rotation about the Y-axis,as has been previously mentioned, may in turn be configured to imposevarus-valgus movement upon an associated positioned patient's leg.

It should also be noted, with reference to FIGS. 4-5 and 7, and as willbe described in further detail below in the context of operation of theRKT device 10, the pair of bearings 1102 and the flange adaptor 1103,which operatively connect the Y-axis drive assembly 2100 and the slidingframe assembly 1100 relative to the pivoting plate assembly 1200 areconfigured such that rotation about the Y-axis results in correspondingmovement of the foot plate 1300 and thus the patient's foot and/or tibiaabout the same. Such movements, imposed as the result of operation will,however, be described in further detail elsewhere herein.

4. Pivoting Plate Assembly 1200

Returning now with particular emphasis upon FIG. 4, the pivoting plateassembly 1200 of the tibia positioning assembly 1000 is illustrated. Thepivoting plate assembly 1200 according to various embodiments comprisesa pivoting plate 1201, which is mounted relative to the sliding framemembers 1101 of the sliding frame assembly 1100 (see, e.g., FIG. 7). Incertain embodiments, as illustrated in FIG. 4, the pivoting plate 1201is mounted to the frame cap assembly 1110 (see again FIG. 7), so as toalso provide a platform for supporting the X-axis and Z-axis driveassemblies 2000, 2200, the configuration of which as will be describedelsewhere herein.

In various embodiments, as mentioned, the pivoting plate assembly 1200comprises a pivoting plate 1201 that is mounted to the frame capassembly 1110. In this manner, the mounting of the pivoting plate 1201relative to the frame cap assembly 1110 serves to fixedly couplemovement of the pivot plate 1201 to movement imposed by the Y-axis driveassembly 2100 about the Y-axis.

The pivoting plate assembly 1200 according to various embodimentsfurther comprises a pair of L-shaped flange brackets 1210 (see FIG. 4),each configured to be mounted on opposing ends of the pivoting plate1201, such that the X-axis drive assembly 2000 may be mountedthere-between. In certain embodiments, as may be seen in FIG. 4, each ofthe L-shaped flange brackets 1210 may comprise an opening configured toreceive at least a portion of the X-axis drive assembly 2000. In atleast the illustrated embodiment, the pivoting plate assembly 1200further comprises a bearing 1211 and a stub flange 1212, each of whichare mounted adjacent the second of the two L-shaped flange brackets1210, namely further adjacent the drive motor 2010 of the X-axis driveassembly 2000. A flange bracket 1213 is similarly attached adjacent thefirst of the two L-shaped brackets 1210, namely substantially adjacentthe gear box 2020 of the X-axis drive assembly 2000. In this manner, theL-shaped flange brackets 1210 provide stable support for the X-axisdrive assembly 2000.

With continued reference to FIG. 4, it should be understood that theconfiguration of the previously described components of the pivotingplate assembly 1200 relative to the X-axis drive assembly 2000 areconfigured such that rotation of the X-axis drive assembly substantiallyabout the X axis (see FIG. 5) translates into rotational movement of theyoke assembly 1400 and the calf bias assembly 1500, both as will bedescribed in further detail below. Such movement is imparted due, atleast in part, to the further mounting of the flange bracket 1213 andthe stub flange 1212 of the pivoting plate assembly 1200 to opposingones of a pair of side leg members 1510 of the yoke assembly 1500,again, as will be detailed further below.

Beyond the above-described components of the pivoting plate assembly1200 configured to support and/or translate movement imposed by theX-axis drive assembly 2000, the plate assembly 1200 further comprisesaccording to various embodiments certain components configured tosupport the Z-axis drive assembly 2200. In particular, with continuedreference to FIG. 4, it may be seen that the pivoting plate assembly1200 in certain embodiments further comprises an L bracket 1220, aflange adaptor 1221, and a torque transducer 1222, all oriented relativeto and along the Z-axis.

The L bracket 1220 according to various embodiments is mounted to thepivoting plate 1201 such that it is oriented substantially perpendicularrelative to the pair of L-shaped flange brackets 1210 describedpreviously herein as being configured for supporting the X-axis driveassembly 2000. In this manner, as illustrated further in FIGS. 5-6, itshould be understood that the X-axis drive assembly 2000 and the Z-axisdrive assembly 2200 are likewise positioned substantially perpendicularrelative to one another, so as to provide respective rotation about thelikewise mutually perpendicular X and Z axes.

The flange adaptor 1221 and the torque transducer 1222 are likewisemounted to the L bracket 1220 and the foot plate 1300 (describedelsewhere herein), such that rotational movement of the Z-axis driveassembly 2200 is converted into a rotational force about the Z-axis thatis not only measured by the torque transducer 1222 (e.g., to ensure anappropriate or desired force is supplied/imposed) but also transferredonto the foot plate 1300, resulting in corresponding rotational movementthereof about the Z-axis. Notably, as will be described further below,the rotational movement of the foot plate 1300 about the Z-axis isconfigured to provide internal and/or external rotation a patient'stibia during operational testing performed according to variousembodiments.

5. Foot Rotation Assembly 1300

According to various embodiments, as may be understood from at leastFIGS. 3-4 and 7, the foot plate assembly 1300 of each of the tibiapositioning assemblies 1000 may be pivotably mounted relative to thepivoting plate assembly 1200 of the (linearly) sliding frame assembly1100 via the Z-axis drive assembly 2200, as will be described in furtherdetail below. In certain embodiments, the foot plate assembly 1300 isconfigured to rotate about the Z axis in response to rotation of (e.g.,to) an output shaft 2230 of the Z axis drive assembly 2200 (see alsoFIG. 7), as will also be described in further detail below. In these andstill other embodiments, with reference also to FIG. 4, the foot plateassembly 1300 is mounted in series to the torque transducer 1222, theflange adapter 1221, and the L bracket 1220 of the pivoting plateassembly 1200.

With reference again to FIG. 3 and also to FIG. 10, it should beunderstood that rotation of the foot plate assembly 1300 about the Zaxis, as imposed by the Z-axis drive assembly 2200 is configured toprovide movement for tibia internal and external rotation testing.Details of the drive assembly 2200 will be described in further detailbelow in the context of operational parameters of the RKT device 10.

It should also be understood, however, that rotation of the pivotingplate assembly 1200 about the Y axis, via the “Y” Axis drive assemblywill also impose movement upon the foot plate 1300, namely via its fixedmounting relative to at least the pivoting plate assembly about the “Y”axis. In other words, in certain embodiments, although the foot plate1300 may be configured to rotate about the Z axis, it may also beconfigured to move (e.g., to swivel) in response to rotation of thepivoting plate assembly 1200 about the Y axis, all as will be describedin further detail below.

6. Yoke Assembly 1400

Returning to FIGS. 3-4 and 7, various embodiments of the tibiapositioning assembly 1000 further comprise a yoke assembly 1400. Incertain embodiments, the yoke assembly 1400 comprises a yoke top plate1410, a pair of yoke end plates 1420, and at least one limit plate 1430.Each of these components may be seen, in particular, in the explodedview of FIG. 4.

Indeed, with particular reference to FIG. 4, the yoke end plates 1420are generally configured according to various embodiments to operativelymount, respectively, to the flange bracket 1213 and the stub flange 1212of the pivoting plate assembly 1200, as such components have beenpreviously described herein. In certain embodiments, respective side legmembers 1510 of a calf bias assembly 1500, as will be described below,may be positioned intermediate the yoke end plates 1420 and therespective flange bracket 1213 and stub flange 1212. In this manner, aswill be described in further detail below, rotational forces imposed byrotational movement of the X-axis drive assembly 2000 about the X-axismay be transferred from the drive assembly 2000 and onto both the sideleg members 1510 of the calf bias assembly 1500 and the yoke end plates1420 of the yoke assembly 1400.

Remaining with FIG. 4 and also with reference to FIG. 5, it may be seenthat the yoke top plate 1410 is, according to various embodiments,positioned so as to extend substantially between the respective yoke endplates 1410. In this manner, as rotational movement of the X-axis driveassembly 2000 transfers rotational movement onto the yoke end plates1420, the latter further transfers the same rotational movement onto theyoke top plate 1410. In certain embodiments, the limit plate 1430 of theyoke assembly 1400 may be further configured with at least two rubberstops that are positioned so as to contact opposing sides of the yoketop plate 1410 and thus define a “limited” range of motion thereof, inresponse to rotational movement imposed by the X-axis drive assembly2000. In this manner, a degree of movement and/or force and/or torquethat may be imposed upon a patient's limb may be restricted for jointprotection and/or patient comfort

Still further, it should be appreciated that the yoke assembly 1400, andin particular, the yoke end plates 1420 are further configured totransfer rotational movement imposed by the X-axis drive assembly 2000onto at least the side leg members 1510 of the calf bias assembly 1500,as described immediately below. Of course, in certain embodiments, itshould be appreciated that it is the flange bracket 1213 and the stubflange 1212 of the pivot plate assembly 1200 and their respectivelyfixed mounts to each of the yoke end plates 1420 and the side legmembers 1510 that transfers the rotational movement thereupon. In otherembodiments, the yoke assembly 1400 may be otherwise configured, as maybe desirable for particular applications.

Returning for a moment to FIG. 4, with reference also to FIGS. 10-11, itshould be appreciated that the above-described transference ofrotational force (and thus movement) from the X-axis drive assembly 2000is configured such that the RKT device 10 may pivot, as illustrated,along the X-axis, so as to move a patient's tibia from the illustratedposition of FIG. 10 to that of FIG. 11 (and vice versa). Of course, suchrotation involves not only rotational movement of the yoke assembly 1400about the X-axis, but also the same by the calf bias assembly 1500,which will now be described immediately below. As also described infurther detail below, in certain embodiments, such movement may imposerotational movement of the patient's limb, whether about the same X-axisor about a secondary and parallel X-axis, as may be seen in at leastFIG. 10. These and other features, as may be appreciated better withconsideration to relative movements imposed during operation of the RKTdevice will be described in further detail below.

7. Calf Bias Assembly 1500

According to various embodiments, returning again to FIG. 4, the tibiapositioning assembly 1000 further comprises a calf bias assembly 1500,which may itself comprise a pair of side leg members 1510, a cross plate1520, a torque transducer 1530, a stub flange 1540, a bearing 1550, atelescoping rod assembly 1560, and a calf bias plate 1570.

With continued reference to FIG. 4, the pair of side leg members 1510are, according to various embodiments, fixedly attached at a first endthereof to the flange bracket 1213 and the stub flange 1212 of thepivoting plate assembly 1200, which also supports at least the X-axisdrive assembly 2000 and the yoke assembly 1400. In this manner (i.e.,via this connection/attachment), the calf bias assembly 1500 is likewisesupported by the pivoting plate assembly 1200 according to variousembodiments.

Opposing ends of the side leg members 1510 are configured according tovarious embodiments to mate with either a stub flange 1540/bearing 1550pairing or a torque transducer 1530. Such is configured substantiallythe same as the torque transducer 1222 and the bearing 1211/stub flange1212 pairing previously described herein. In other words, the torquetransducer 1530 is configured to measure and transfer a force imposedupon the side leg members 1510 by the X axis drive assembly 2000 onto atleast the plate 1520 and/or the calf bias plate 1570 of the calf biasassembly 1500.

Returning to FIG. 4, a plate 1520 and a telescoping rod assembly 1560are also provided and configured to fixedly link the torque transducer1530 to the calf bias plate 1570. With reference to FIGS. 10-11, and aswill be described in further detail below, this configurationfacilitates transfer of the rotational force (and thus torque) imposedupon the yoke assembly 1400 by the X-axis drive assembly 2000 onto notonly the calf bias assembly 1500, but also the patient's tibiapositioned substantially adjacent to the calf bias plate 1570. Indeed,as should be understood from these figures, imposing a force in theclockwise direction (relative to FIGS. 10-11, in particular) results ina substantially “upward” movement of the tibia, further accompanied byrotation about the illustrated tibia pivot point. In this manner, aswill be described in further detail, activation of the X axis driveassembly results in forces being applied to the tibia substantiallyalong the Y axis in the anterior and/or posterior direction relative tothe tibia.

Although reference has been made herein to a telescoping rod assembly1560, which should be understood to be extendable in length (e.g.,between the calf bias plate 1570 and the plate 1520 adjacent thepivoting plate assembly 1200, certain embodiments may have otherwiseconfigured assemblies 1560, provided such are capable of accommodatingdiffering lengths of patient's legs positioned adjacent thereto. Instill other embodiments, the rod assembly 1560 may even not beadjustable, in a telescoping fashion or otherwise, as may be desirablefor particular applications.

8. “X”-Axis Drive Assembly 2000

Remaining with FIG. 4, the X-axis drive assembly 2000 is illustrated, asconfigured such that a longitudinal axis thereof lies substantiallyalong the further illustrated X-axis, as also defined in at least FIG.5. With reference to FIGS. 7 and 12, it should be understood thatvarious embodiments of the X-axis drive assembly 2000 comprise a drivemotor 2010, a gear box 2020, and an output shaft 2030 operativelycoupled to the gear box.

In certain embodiments, the drive motor 2010 may comprise a servomotorconfigured to provide a rotational force, although still otherembodiments may include alternative mechanical or even manual methods offorce generation and application, as may be desirable for particularapplications and as commonly known and understood in the art. Of course,it should be understood that any of a variety of alternativeconfigurations may be envisioned as within the scope of the presentinvention, as may be desirable for a given application.

In certain embodiments, the drive motor 2010, however particularlyconfigured, may be at least configured with a housing mounted relativeto the pivoting plate assembly 1200, such that the drive motor drivesthe corresponding output shaft 2030, which itself drives at least theyoke assembly 1400 and the calf bias assembly 1500 based upon thestructural relationships previously described herein. In this manner,according to various embodiments, the X-axis drive assembly 2000 isconfigured to facilitate rotation of at least a portion of the RKTdevice 10 about the X-axis (see FIG. 5), such that a user of the devicemay evaluate “AP” (anterior-posterior) movement of the tibia withrespect to the femur at the knee about an X-axis of rotation distal tothe foot.

9. “Y”-Axis Drive Assembly 2100

Turning now with particular reference to FIG. 7, the Y-axis driveassembly 2100 is illustrated, as may be configured according to variousembodiments such that a longitudinal axis thereof lies substantiallyalong the Y-axis, the latter of which as is defined in at least FIG. 5.With reference to FIG. 12, it should be understood that variousembodiments of the Y-axis drive assembly 2100 comprise a drive motor2110, a gear box 2120, and an output shaft 2130 operatively coupled tothe gear box.

In certain embodiments, the drive motor 2110 may comprise a servomotorconfigured to provide a rotational force, although still otherembodiments may include alternative mechanical or even manual methods offorce generation and application, as may be desirable for particularapplications and as commonly known and understood in the art. Of course,it should be understood that any of a variety of alternativeconfigurations may be envisioned as within the scope of the presentinvention, as may be desirable for a given application.

In certain embodiments, the drive motor 2110, however particularlyconfigured, may be at least configured with a housing mounted relativeto the pivoting plate assembly 1200, such that the drive motor drivesthe corresponding output shaft 2130, which itself imposes rotation uponat least the pivoting plate assembly 1200 and the foot plate assembly1300 based upon the structural relationships previously describedherein. In this manner, according to various embodiments, the Y-axisdrive assembly 2100 is configured to facilitate rotation of the footplate assembly 1300 about the Y-axis (see FIG. 6), such that a user ofthe device may evaluate varus-valgus conditions about a Y-axis ofrotation distal to the foot.

10. “Z”-Axis Drive Assembly 2200

Returning again to FIGS. 4 and 12, the Z-axis drive assembly 2200 isillustrated according to various embodiments, as may be configured suchthat a longitudinal axis thereof lies substantially along the Z-axis,the latter of which as is defined in at least FIG. 5. With reference toFIG. 12, it should be understood that various embodiments of the Z-axisdrive assembly 2200 comprise a drive motor 2210, a gear box 2220, and anoutput shaft 2230 operatively coupled to the gear box.

In certain embodiments, the drive motor 2210 may comprise a servomotorconfigured to provide a rotational force, although still otherembodiments may include alternative mechanical or even manual methods offorce generation and application, as may be desirable for particularapplications and as commonly known and understood in the art. Of course,it should be understood that any of a variety of alternativeconfigurations may be envisioned as within the scope of the presentinvention, as may be desirable for a given application.

In certain embodiments, the drive motor 2210, however particularlyconfigured, may be at least configured with a housing mounted relativeto the foot plate assembly 1300 based upon the structural relationshipspreviously described herein. In this manner, according to variousembodiments, the Z-axis drive assembly 2200 is configured to facilitaterotation of the foot plate assembly 1300 about the Z-axis (see FIG. 6),such that a user of the device may evaluate (internal-external) movementabout a Z-axis of rotation.

It should further be understood that any of the X-, Y-, or Z-axis driveassemblies 2000-2200 may be structurally configured substantially thesame relative to one another, with the only substantive difference beingthe relative axis of rotation about which each is oriented. Of course,it should also be understood that any of a variety of alternativeconfigurations may be envisioned as within the scope of the presentinvention, as may be desirable for a given application.

It should also be understood that although in certain embodiments, theX-, Y-, and/or Z-axis drive assemblies 2000-2200 may be oriented suchthat at least two thereof are mutually orthogonal and intersectingrelative to one another, in other embodiments, one or more of the driveassemblies 2000-2200 may be offset relative to the remainder of thedrive assemblies, such that non-intersecting, although orthogonal axesare defined. This feature and further variations thereof are describedin further detail elsewhere herein, and may be understood generally withreference to at least FIG. 7 (showing how the Y and X axis may be offsetrelative to one another, as along a longitudinal axis of the RKT devicein its entirety); FIGS. 8 and 9 (showing the same relative offsetbetween the X and Y axes, when viewed in combination); and FIGS. 13-15(as will be described elsewhere herein).

B) Overall Operation

Each of the various above-described features and their use will now bedescribed in further detail herein-below.

1. Generally

Three drive assemblies are used, namely a “X” axis drive assembly 2000,a “Y” axis drive assembly 2100, and a “Z” axis drive assembly 2200. Eachdrive assembly can be understood to include, in various embodiments, amounting frame, a drive motor and a gearbox having an output shaft, asall previously described herein. By operation of any of the drivemotors, rotational movement is provided to a corresponding output shaftwith intermediate reduction (or expansion) gearing as needed to provideadequate torque and rotational speed.

According to various embodiments, torque sensors are provided in thepower line in order to provide torque readings as known in the artrelating to each of these three drive assemblies. These torque readingsmay be calibrated and calculated as needed to correspond to known torqueor force values imparted to a patient's limb(s).

As noted elsewhere, movement of the patient's body parts may be detectedby non-invasive systems utilizes sensors or markers that are attached tothe skin, including but not limited to vision, optoelectronic,ultrasonic, and electromagnetic motion analysis systems.

The three drive assemblies are configured about mutually perpendicularX-, Y-, and Z-axes of rotation, as illustrated in at least FIG. 5. Assuch, the respective forces (and corresponding torque) imposed by thedrive assemblies are configured to selectively evaluate “AP”(anterior-posterior) movement of the tibia with respect to the femur atthe knee about the X-axis of rotation distal to the foot, varus-valgusconditions about the Y-axis of rotation distal to the foot, and “IE”(internal-external) movement about the Z-axis of rotation. Similarly,motions can be defined in such a way as to be relative to a co-ordinatesystem defined by the tibia as opposed to the femur.

According to various embodiments, the patella is clamped in place forall three types of testing procedures. In these and still otherembodiments, a strap (not illustrated) may be coupled with the calf biasplate of assembly 1500 for use only during AP testing. Such astrap/plate or cage or box assembly may be configured as commonly knownand understood in the art so as to provide selective restraint of theuser's limb (e.g., as a non-limiting example, the strap may beoperatively connected to one or the other sides of the calf bias plate1570 and selectively attachable (e.g., via Velcro or the like) on theopposing side, with the strap also being in certain embodiments,selectively adjustable, as may be desirable). The strap/plate, cage orbox assembly could be situated such that all sides are in constantcontact with the calf or it could be configured such that there is spacebetween the strap/plate, cage or box assembly and the calf. When thereis space the assembly will move for a small distance before it contactsthe calf and applies appropriate forces.

2. X-Axis Drive Operation due to Component Relationships

Movement about the X axis is configured to provide “AP”(anterior-posterior) movement of the tibia, due to forces up or down onthe tibia as the foot is maintained in a stationary position by the footplate assembly 1300. In particular, the tibia pivots about an X orientedaxis passing through the ankle—note this is a different X axis (albeitparallel) to the X axis “of the machine”, aka the “machine X axis,” allof which may be understood with reference to FIG. 11.

With reference to FIG. 4, according to various embodiments, the X driveassembly 2000 has its frame attached to the first of the two L-shapedflange brackets 1210, which is itself attached to the pivoting plate1201. The output shaft of the X drive assembly goes through the hole inthe L-shaped flange bracket (1st of 2), which in certain embodiments hasa larger hole than its sister L-shaped bracket (2^(nd) of 2). The outputshaft of the X drive assembly drives a flange bracket 1213, which drivesone end of a side leg member 1510 of the calf bias assembly 1500, aspreviously described herein. A yoke end plate 1420 and the flangebracket 1213 sandwich the end of the side leg member, such that relativemovement is transferred there-between during operation.

The yoke end plate 1420 is part of a rigid yoke assembly 1400 thatincludes a yoke top plate 1410 and two yoke end plates 1420. Notably,during operation according to various embodiments, as the 1^(st) of thetwo yoke end plates rotate about the X axis so does the entire yokeassembly 1400. The 2^(nd) yoke end plate 1420 is attached to the upperone end of a 2^(nd) of two side leg members 1510 of the calf biasassembly 1500, with that end also being attached to a stub flange 1212that is pivotably mounted relative to the 2^(nd) of two flange brackets.The bearing 1211 supporting the stub flange 1212 does not interact withthe X axis drive assembly 2000, such that the X axis drive assembly isthus solely supported by the 1^(st) of two flange brackets 1210, asattached to the pivoting plate 1201.

As previously described herein, the lower end of the 1^(st) of two sideleg members 1510 is attached to a spool-shaped torque transducer 1530,which is itself attached to a plate 1520 which supports a telescopingrod assembly 1560 that supports a calf bias plate 1570.

The lower end of the 2^(nd) of 2 side leg members 1510 has a bearing1550 attached thereto, which supports stub flange 1540. This stub flange1540 is attached to the end of the plate 1520 opposite the spool-shapedtorque transducer.

In this manner, upon activation of the X-axis drive assembly, anyrotational force generated by the drive thereof is transferred to theassociated gear box 2020 and output shaft 2030, the latter of whichrotates the flange bracket 1213. Rotation of the flange bracket 1213causes rotation of the side leg member 1510 of the calf bias assembly1500, which is operatively coupled to the calf bias plate 1570 via atleast a telescoping rod assembly 1560, which may include one or moretelescoping rods configured to accommodate varying patient limb lengths.

The resulting movement imposed upon the calf bias plate 1570 is furtherillustrated in FIGS. 10-11, wherein pre- and post-movement positions arerespectively shown. As may be further understood from these figures,rotation occurs not only about the X-axis about which the X driveassembly 2000, but also about a tibia pivot point about a stationaryconstrained ankle, as restrained in the foot rotation assembly 1300. Inthis manner, a user of the device may selectively evaluate “AP”(anterior-posterior) movement of the tibia with respect to the femur atthe knee about an X-axis of rotation distal to the foot. In certainembodiments, such selective evaluation involves selective locking of theone or more of the remaining Y- and Z-axis drive assemblies, uponactivation of the X-axis drive assembly 2000. This selective locking canresult in the foot remaining still while the x-axis motor rotates aboutthe X-axis distal to the foot resulting in the calf being manipulated inthe anterior-posterior direction representing Y-axis translation.

3. Y-Axis Drive Operation due to Component Relationships

The Y-Axis drive assembly 2100 is configured according to variousembodiments to rotate the foot plate about the Y axis relative to thesliding frame assembly 1100, so as to evaluate varus-valgus conditions.The strap associated with the calf support member is not used. Howeverthe patella is clamped in place, as previously described herein.

As described previously herein with reference to FIG. 7, the frame ofthe Y axis drive assembly 2100 is attached to the underside of thepivoting plate 1201 (see also FIG. 4), and includes an output shaft 2130that extends upwardly through a hole in the pivot plate. This outputshaft 2130 attaches to a flange adaptor 1103 that attaches to a Y torquetransducer 1104, which in turn attaches to a frame cap assembly 1110,which attaches to the pivoting plate 1201, all as also previouslydescribed herein. The torque transducer 1104 thus evaluates the torquealong the drive line between the output shaft 2130 and the pivotingplate 1201.

With continued reference to FIGS. 4 and 7, it may be understood thatbecause the output shaft 2130 of the Y-axis drive assembly 2100 and thefoot plate 1300 are both fixedly attached to the pivoting plate (e.g.,the latter via the L bracket 1220, as previously described herein),rotation transferred from the Y-axis drive assembly 2100 onto thepivoting plate 1201, resulting in it pivoting about the Y axis, is thustransferred further onto the foot plate 1300, also causing it to moveabout the Y axis. Notably, when such occurs without concurrentrotational transfer from the Z-axis drive assembly 2100, movement of thefoot plate 1300 will thus be isolated to about the Y axis, with norotation occurring about the Z-axis.

During operation, such isolated rotation about the Y axis facilitatesevaluation of varus-valgus conditions about the Y-axis of rotation, aspreviously described herein. Note that rotation of about the Y-axisdistal to the foot causes the foot to move in an X-axis translationwhich results in a Y-axis rotation about the knee. It is this Y-axisrotation at the knee that is the varus-valgus rotation. Note that thedistance from the footplate to the motor determines how far thefootplate will translate along the X-axis. The more the footplatetranslates along the X-axis the more varus-valgus movement is effectedat the knee. Furthermore, the Y-axis motor may be position such that itmoves the footplate but that the X-axis motor and/or the Z-axis motorare not moved during the process.

4. Z-Axis Drive Components and Operation

The Z-Axis drive assembly is configured to rotate the foot plate aboutthe Z axis relative to the sliding frame member, so as to evaluate “IE”(internal-external) rotational movement of the patient's tibia and/orlimb. The strap associated with the calf support member is not used.

With reference to FIG. 4, the foot plate 1300 is attached to a torquetransducer “IE” (internal-external) movement 1222 which is attached to aflange adaptor 1221 which is attached to the output shaft 2330 (see FIG.12) of the Z-Axis drive assembly 2300. The frame of the Z-Axis driveassembly is attached to an L Bracket 1220 which is fixedly attached tothe pivot plate 1201, as described elsewhere. Also as describedelsewhere, the pivot plate 1201 is attached relative to the linearlysliding frame assembly 1100 about a pivoting axis Y. However, if theY-Axis drive assembly is not in use and is selectively locked (which itis capable of, as are the other two), then the pivot plate 1201 islikewise substantially rigidly attached relative to the sliding frameassembly 1200.

In this manner, upon activation of the Z-axis drive assembly 2200, arotational movement and accompanying torque are transferred via theoutput shaft 2330 directly to the foot plate 1300, thereby providingresulting rotation of the foot plate about the Z-axis. Such permitsusers to, amongst other things, evaluate “IE” (internal-external)rotational movement of the patient's tibia and/or limb.

5. Right Versus Left Oriented Tibia Positioning Assemblies 1000

Although it has been previously described herein with reference to FIG.2, it should be again noted that although only one tibia positioningassembly 1000 has been described herein, various embodiments of theoverall RKT device 10 comprise two such assemblies 1000. In certainembodiments, the two assemblies are symmetrical mirror images of oneanother, about a center-line axis of the device 10 as a whole. In thismanner, it should be understood that, as a non-limiting example, if thesame activation signal is sent to each of the X-axis drive assemblies2000, the resulting movement of each will result in anterior movement ofboth of the user's tibias. Consider the alternative, in the absence of asymmetrical mirror image configuration, in which instance such a signalwould result in anterior movement of one tibia and posterior movement ofthe other. Although such a nonsymmetrical configuration may be desirablein at least one embodiment, it should be understood that according tocertain embodiments described herein, the assemblies 1000 should beunderstood to be substantially symmetrically configured.

Still further, it should be understood that although the previousdescription has focused upon a single tibia positioning assembly 1000,both of the assemblies of the overall RKT device 10 are according tocertain embodiments configured, sized, and shaped in substantially thesame manner. Of course, it should also be appreciated that in stillother embodiments, it may be desirable to have substantially differentlysized, shaped, and/or configured tibia positioning assemblies 1000, suchas the non-limiting example whereby at least one of the two assembliessubstantially corresponds to the tibia positioning assembly described inSer. No. 13/209,380, as has been incorporated by reference herein in itsentirety.

6. Drive Assembly Decoupling

It should be understood that any drive assembly configuration 2000-2200may be according to various embodiments decoupled from any of the othertwo. In fact, each of the three drive configurations could be decoupledfrom each of the other two so that substantially independent rotationabout the respective axes thereof may be provided and thus imposed uponthe patient's limb, as may be desirable for particular applications. Instill other embodiments, it should be understood that two or more, andeven all three drive assemblies 2000-2200 may be mutually coupledrelative to one another such that movements are substantiallysimultaneously imposed upon the patient's limb during operation of theoverall RKT device. That being said, it is often advantageous to isolateeach respective movement; thus isolation (i.e., decoupling) of themovements of each of the respective drive assemblies 2000-2200 may belikewise desirable for particular applications as have been describedelsewhere herein.

C) Additional Configurations

1. Spherical Configurations

Spherical configurations can be also be used to provide manipulation ofthe lower leg of a patient about the centers of the spheres.

FIG. 13 is an alternate configuration showing the use of sphericalelements 3001, 3002 for manipulating the lower leg of a patient (shownin dotted line) about the centers of the spheres.

Sphere 3001 is driven by the exemplary roller and drive assembly (whichcan include two rollers and one cylindrical drive member as known in the“mouse-ball” art). Depending on the number of and orientation of rollerand drive assemblies used in conjunction with the sphere 3001, it may beunderstood that the sphere 3001 may be rotated about its center C1 abouta number of rotational axes passing through the center C1, including atleast three mutually orthogonal axes. In this configuration the CenterC1 is approximately in the center of the ankle of the user.

Sphere 3002 is driven by the exemplary roller and drive assembly (whichcan also include two rollers and one cylindrical drive member as knownin the “mouse-ball” art, although these are not shown). Depending on thenumber of and orientation of roller and drive assemblies used inconjunction with the sphere 3002, it may be understood that the sphere3002 may be rotated about its center C2 about a number of rotationalaxes passing through the center C2, including at least three mutuallyorthogonal axes. In this configuration the Center C2 is distal to theankle and foot of the user.

It may be understood, therefore, that such a spherical-basedconfiguration could be used to provide at least some of the rotationalmovements described in association with FIGS. 1-12.

FIG. 14 is an alternate configuration showing the use of a sphericalelement 3003, except that the center of rotation C3 is even furtherdistal to the foot, and an exemplary calf bias member (aka extender bar)is also used for the AP movement only, with the two other movementsbeing provided without the bias member.

FIG. 15 shows an alternate configuration including a spherical cage 4000comprised of a plurality of cage bars 4005. Rotation of the cage is doneby use of one or more stationary motors such as 4010.

Stationary motor 4010 and rollers 4020 are mounted relative to framemember 4011. Motor 4010 drives rollers 4020, with the two rollerscapturing an associated cage bar. This rotation of the spherical cage4000 can be provided about an axis extending through the center of thecage and normal to a plane including the particular arcuate cage bar.Either of or both rollers can drive the bar. The point of this is toillustrate that many types of drive configurations can be used toprovide the motions in certain of the embodiments herein, either fromthe inside of the sphere, or the outside.

2. Additional RKT Features

Note that the semicircular notch (not numbered) in the pivoting plate1201 (see for example just under the “Z” axis DRIVE ASSEMBLY 2200 inFIG. 4) is configured to accept a vertical support shaft (not shown)which is anchored at its base and extends upwardly through the plate.The shaft has two slide bearings (not shown) on either side which bearon the two primary planar surfaces of the pivoting plate. This limits upand down deflection of the plate from its pivot point during the APtesting process. During the Y-axis movement, the shaft moves within theslot.

As previously mentioned, it should be understood that any driveconfiguration could be decoupled from any of the other two—in fact, eachof the three drive configurations could be decoupled from each of theother two so that substantially independent rotation about therespective axes thereof may be provided and thus imposed upon thepatient's limb, however, as may be desirable for particularapplications.

In still other embodiments, it should be understood that two or more,and even all three drive assemblies 2000-2200 may be mutually coupledrelative to one another such that movements are substantiallysimultaneously imposed upon the patient's limb during operation of theoverall RKT device. That being said, it is often advantageous to isolateeach respective movement; thus isolation (i.e., decoupling) of themovements of each of the respective drive assemblies 2000-2200 may belikewise desirable for particular applications as have been describedelsewhere herein.

3. RKT Device for CT Scanning

Additional details regarding imaging protocols, including the use of CTscanning components in conjunction with limb and ligament evaluationapparatuses may be found in Applicant's commonly owned U.S. PatentApplication Publication No. 2012/0046540-A1 (also Ser. No. 13/209,380),as published on Feb. 23, 2012 and filed on Aug. 13, 2011, which ishereby incorporated by reference in its entirety.

Further very general disclosure of incorporation of CT scanningcomponents within limb and ligament evaluation apparatuses may be foundin Applicant's commonly owned U.S. Patent Application Publication No.2009/0124936-A1 (also Ser. No. 12/267,109), as published on May 14, 2009and filed on Nov. 7, 2008, which is hereby incorporated by reference inits entirety.

Here begins a discussion of a second embodiment RKT device 5000, whichincludes similarities to the above-described RKT device B, but alsoincludes differences. Some of these differences facilitate its use inconjunction with a CT scanner to evaluate the knee of a human. However,it should be understood that this is not to be limited to such scannersor joints, and is only an example. The device 5000 could also be used inconjunction with MRI or other scanners, and indeed some of its featuresmay be used with sensors such as those used with the non-radiographicdevice 10 above, which include non-invasive systems utilizing sensors ormarkers that are attached to the skin, including but not limited tooptoelectronic, ultrasonic, and electromagnetic motion analysis systems.

Reference is first made to FIG. 17, which is a side illustrative view ofa leg testing apparatus 5000 according to one of the inventions herein,in combination with an exemplary CT scanner 4900, and a patient's bodysupport apparatus 4950. The three devices are configured to be typicallysituated atop an unnumbered supporting surface. Also shown is anexemplary patient, including a patient proper body 4951, patient lowerleg 4950, and patient upper leg 4950.

It may be understood that inventions and novelties relate to and includethe leg testing apparatus 5000 and its use on its own, as well as theleg testing apparatus 5000 and its use in combination with the CTscanner 4900, as well as the leg testing apparatus 5000 and its use incombination with the patient body support apparatus 4950, as well as thethree components 5000, 4950, and 4900 together.

As may be understood, the leg testing apparatus 5000 manipulates the legof the patient, while the patient is supported on the patient bodysupport apparatus 4950. A portion of the patient's body, in this examplethe lower leg, is shown in FIG. 17 as within the opening of the CTscanner 4900, such that the lower leg can be scanned by the CT scanner.This scanning may be done while the leg testing apparatus is in any oneof a multiplicity of modes of operation, including but not limited toits testing of the patients knee in “AP” (anterior-posterior) movement,varus-valgus movement, and/or internal and external rotation.

The upper torso of the patient is supported by the patient body supportapparatus 4950, which includes a back support 4956 (upon which thepatient lies), which supports a thigh restraint assembly 4952 (whichcontains the upper thighs of the patient), and which also supports ashoulder restraint 4959 (which serve to discourage the patient frommoving to the right as FIG. 17 is viewed.

It may be understood that under one embodiment of the invention, thepatient body support apparatus 4950 includes a structural link member4951 which connects to the leg testing apparatus 5000, to allow the twoto slide together as a unit (with both 5000 being on rollers or suitablyaligned tracks). Alternately, the two members could be separately drivenvia coordinated synchronized drive means.

Reference is now made to FIG. 18, which is a perspective view of a legtesting apparatus 5000 according to one aspect of the presentinventions, which includes left lower leg supporting apparatus 5200,right lower leg supporting apparatus 5300, and lower frame number 5100.

As may be seen, in FIG. 18, the “Z” axes of the two apparatuses 5200,and 5300, are not aligned with each other. These two axes are referencedas “Z axis—left”, the Z axis of the left apparatus 5200, and “Zaxis—right”, the Z axis of the right apparatus 5300. The Z axis forpurpose of this discussion should be understood as the axis of rotationof the foot plate as discussed in later detail

In FIG. 18, these two Z axes are positioned in “alignment” with theirrelated calf bias assemblies 5260, 5360. However it will be understoodfrom later discussion that while the positions of the “Z” axes of thetwo apparatuses 5200 and 5300 can be varied, the calf bias assembliesare not configured to rotate about a vertical axis (although they caneach rotate about their own horizontal “X” axis to provide an APaction). This is to accommodate the use of the apparatus 5000 within therelatively narrow space within the CT scanner.

FIG. 19 is a top elevation view of the leg testing apparatus 5000 ofFIG. 18, illustrating the relationship of the left lower leg supportingapparatus 5200 and the right lower leg supporting apparatus 5300,relative to the inner surface of the scanning device 4900. As may beseen, the “X” axes of the two apparatuses 5200, and 5300, are also notaligned, and in the embodiment shown, the angle between the two isfixed.

FIG. 20 is a rear elevation view of the leg testing apparatus 5000 ofFIG. 18, which includes left lower leg supporting apparatus 5200, rightlower leg supporting apparatus 5300, and lower frame number 5100. FIG.21 is a front elevation view of the same leg testing apparatus 5000.

FIG. 22 is a pictorial view of the right lower leg supporting apparatus5300, with certain elements not included for purposes of explanation. Inreference to this as well as Figures G and H—for example, here follows adescription of right leg supporting apparatus 5300; a similardescription could be made of left lower leg supporting apparatus 5200,as the two are essentially mirror images of each other.

The right lower leg supporting apparatus 5300 is slidably mountedrelative to the lower frame member via slide assemblies 5101, such thatthe two apparatuses 5200, 5300, slide in tandem along parallel slidepaths. There are smaller slide mounts that allow 5200 and 5300 to slideindependently along the same path.

The two slide assemblies 5101 are attached to the bottom ofcorresponding two lower vertical frame members 5310. A lower frame table5312 is rigidly attached to the top of the two lower vertical framemembers 5310.

Two intermediate vertical frame members 5314 are rigidly attached to thetop of the lower frame table 5312. An intermediate frame table 5320 isrigidly attached to the top of the two intermediate vertical framemembers 5314.

Two short upper vertical frame members 5322 are rigidly attached to thetop of the upper frame table 5312. An upper frame table 5333 is rigidlyattached to the top of the two short upper vertical frame members 5322.

Two long upper vertical frame members 5332 are also rigidly attached tothe top of the upper frame table 5312. These frame members support the Xdrive assembly 5600 in a manner similar to that described in theapparatus earlier in this application.

4. “X”-Axis Drive Assembly 5600 Construction and Operation

The “X”-axis Drive Assembly 5600 is configured to drive the calf biasassembly 5360 substantially about the X axis, similar to the manner inwhich the calf bias assembly 1500 of the device 10 described above wasdriven by its “X”-axis Drive Assembly 2000. Torque about the X axis isalso similarly determined by a similar torque transducer. As in device10, this provides for an evaluation of “AP” (anterior-posterior)movement of the tibia with respect to the femur at the knee about anX-axis of rotation distal to the foot. It should be understood that suchan evaluation, as with any of the movements herein, includes anevaluation of the degree of rotation or pivot as well as the torqueinvolved during such rotation or pivoting.

5. “Y” Drive Assembly Construction and Operation

The “Y” Drive Assembly 5500 is configured to pivot the foot plate 5344about the horizontal Y axis, such that a foot captured by the foot platecauses varus valgus conditions prompted by forces about a Y-axis ofrotation distal to the foot.

The associated Y drive configuration is different than its counterpartin the above device 10. The Y drive assembly 5500 is attached to theunderside of lower frame table 5312. It includes an inline reducer and atorque sensor and drives a vertical shaft 5502 which is captured in twobearings, upper and lower bearings 5505 and 5504, respectively. Theupper end of the shaft 5502 is rigidly attached to the pivotinghorizontal foot support plate 5340 via a flange 5507, such that rotationof the shaft causes rotation of the foot support plate 5340.

A shown in FIG. 25, at the front of the pivoting horizontal foot supportplate 5340 is rigidly mounted to a pivoting vertical foot support flange5341. Flange 5341 supports the Z axis drive assembly 5600, such thatoperation of the Z axis drive assembly 5600 causes rotation of the footplate 5344 relative to the flange 5341, about the Z axis. As may beunderstood, this Z axis can be moved within a horizontal plane, viamovement of the “Y” drive assembly.

6. Z Drive Assembly Construction and Operation

As noted above, the Z axis drive assembly 5600 causes rotation of thefoot plate 5344 relative to the support flange 5341, about the Z axis.When a foot is contained in the foot plate, this can provide internaland external rotation of the foot and thus the tibia.

7. More Discussion of Decoupling; Different Movements Possible

One drive is “decoupled” from the other if motion by the first drivedoes not change the position of the second drive in any direction.However, coupling of drive A to drive B does not imply coupling of driveB to drive A. Similarly, decoupling of drive A relative to drive B doesnot imply decoupling of drive B relative to drive A.

This concept extends to multiple drives such that a system can beconfigured to have a complex chain of drives working both dependentlyand/or independently to influence motion of one limb segment withrespect to another limb segment. In a global sense, system A of drivescould influence the system B of drives but not vice versa.

A first drive is coupled to a second drive if motion of the first drivechanges the position of the second drive in any direction. All drivesare ‘decoupled’ when each drive has its own unique independent influenceon the position of the tibia with respect to the femur. In the firstversion described above (leg testing device 10):

-   -   The IE Rotation Drive is decoupled from the AP Drive    -   Both IE Rotation and AP Drives are coupled relative to the        Valgus Drive (movement of Valgus Drive affects axis of the other        two)

In the second version described above (leg testing device 5000)

-   -   AP Drive is totally decoupled    -   Valgus Drive totally decoupled    -   IE Rotation Drive is coupled relative to Valgus Drive (movement        of Valgus affects axis of IE)

In device 5000, this allows for the following actions:

-   -   First place patient limb in extreme internal rotation, then        conduct AP test.    -   First place patient limb in full Valgus as well as full AP, then        do anIErotation test    -   First push patient limb posteriorly, then do varus-valgus test    -   First put patient limb in extreme varus, then do IErotation test    -   First place patient limb in extreme varus and extreme rotation,        then do AP test

8. Output Data

As may be understood, the degrees of the various movements(Varus-Valgus, AP, IE) can be measured by measuring the movements of themachines 10, 5000, themselves, by measuring the degrees of rotation ofthe drives (by encoding for example) and calibrating as necessary. Thetorque encountered during each such movement may also be measured,suitably calibrated to the limb movement, and recorded. In the case ofthe device 10, separate “external” measurement of the limb of thepatient may be detected by non-invasive systems utilizes sensors ormarkers that are attached to the skin, including but not limited tooptoelectronic, ultrasonic, and electromagnetic motion analysis systems.In the case of the device 5000, separate measurement of the movement ofthe limb of the patient may be by using landmarks seen on the actualbones. There are no markers; one can see the bones in the CT images.

9. Testing for Different Degrees of Leg Flexion

It may be understood that during the above tests (AP, varus-valgus, orrotation), there is no flexing of the knee into flexion or extension.However, as shown in FIGS. 26A and 26B, one of the present inventionsalso includes the additional capability to flex the knee into flexion orextension. This would allow for similar tests (such as the examplesabove) done for different degrees of knee flex.

10. Variations

Note that instead of the two apparatuses 5200 and 5300 being commonlyattached to the lower frame member 5100, they could be each be attachedto a separate frame member such that their relative positions on thefloor could be independently varied.

The lower frame member 5100 also slides relative to the floor so thewhole machine can go in and out

III. CONCLUSION

Many modifications and other embodiments of the invention set forthherein will come to mind to one skilled in the art to which thisinvention pertains having the benefit of the teachings presented in theforegoing descriptions and the associated drawings.

Therefore, it is to be understood that the invention is not to belimited to the specific embodiments disclosed and that modifications andother embodiments are intended to be included within the scope of theappended claims. Although specific terms are employed herein, they areused in a generic and descriptive sense only and not for purposes oflimitation.

Although distinct embodiments have been described, the skilled personwill understand how features of different embodiments may be combined.

1-23. (canceled)
 24. A limb manipulation and evaluation devicecomprising: a frame; a first drive supported by the frame and configuredto manipulate a first bone relative to a second bone in a firstdirection about a first axis; a second drive supported by the frame andconfigured to manipulate said first bone relative to said second bone ina second direction about a second axis; and a third drive supported bythe frame and configured to manipulate said first bone relative to saidsecond bone for movement of the first bone in a third direction,wherein: said first, second, and third directions are differentdirections, and at least one drive of the first, second, and thirddrives is mutually decoupled relative to another drive of the first,second, and third drives, such that operation of said one drive does notaffect position of said another drive relative to the frame, and suchthat operation of said another drive does not affect position of saidone drive.
 25. The limb manipulation and evaluation device of claim 24,wherein the first, second, and third directions are orthogonal.
 26. Thelimb manipulation and evaluation device of claim 24, wherein the firstaxis is distal to a foot connected to the first bone.
 27. The limbmanipulation and evaluation device of claim 24, wherein the first andsecond drives are distal to a foot connected to the first bone.
 28. Thelimb manipulation and evaluation device of claim 24, wherein the thirddrive is configured to provide torque about a third axis to move thetibia in the third direction.
 29. The limb manipulation and evaluationdevice of claim 28, wherein the third axis is distal to a foot connectedto the first bone.
 30. A limb manipulation and evaluation devicecomprising: a frame; a first drive supported by the frame and configuredto manipulate a first bone relative to a second bone in a firstdirection, the first bone being connected to the second bone at a joint;a second drive supported by the frame and configured to manipulate saidfirst bone relative to said second bone in a second direction; and athird drive supported by the frame and configured to manipulate saidfirst bone relative to said second bone for movement of the first bonein a third direction, wherein: said first, second, and third directionsare orthogonal directions, and at least one drive of the first, second,and third drives is mutually decoupled relative to another drive of thefirst, second, and third drives, such that operation of said one drivedoes not affect position of said another drive relative to the frame,and such that operation of said another drive does not affect positionof said one drive.
 31. The limb manipulation and evaluation device ofclaim 30, wherein the first drive is distal to a foot connected to thefirst bone.
 32. The limb manipulation and evaluation device of claim 30,wherein the first and second drives are distal to a foot connected tothe first bone.
 33. The limb manipulation and evaluation device of claim30, wherein the third drive is configured to provide torque about athird axis to move the tibia in the third direction.
 34. The limbmanipulation and evaluation device of claim 30, wherein the third driveis distal to a foot connected to the first bone.
 35. A limb manipulationand evaluation device comprising: a frame; a first drive supported bythe frame and configured to manipulate tibia relative to a femur in afirst direction; a second drive supported by the frame and configured tomanipulate said tibia relative to said femur in a second direction; anda third drive supported by the frame and configured to manipulate saidtibia relative to said femur in a third direction, wherein: said first,second, and third directions are different directions, and at least onedrive of the first, second, and third drives is mutually decoupledrelative to another drive of the first, second, and third drives, suchthat operation of said one drive does not affect position of saidanother drive relative to the frame, and such that operation of saidanother drive does not affect position of said one drive.
 36. The limbmanipulation and evaluation device of claim 35, wherein the first,second, and third directions are orthogonal.
 37. The limb manipulationand evaluation device of claim 35, wherein the first drive is distal toa foot connected to the tibia.
 38. The limb manipulation and evaluationdevice of claim 35, wherein the first and second drives are distal to afoot connected to the tibia.
 39. The limb manipulation and evaluationdevice of claim 35, wherein the third direction is anterior-posteriortranslation.
 40. The limb manipulation and evaluation device of claim39, wherein the third drive is configured to provide torque about anaxis to move the tibia in the anterior-posterior direction.
 41. The limbmanipulation and evaluation device of claim 39, wherein the third driveis distal to a foot connected to the tibia.
 42. The limb manipulationand evaluation device of claim 35, wherein the first direction isinternal-external rotation of the tibia.
 43. The limb manipulation andevaluation device of claim 35, wherein the second direction isvarus-valgus rotation of the tibia.